A simple insertion technique to reduce the bending of thinbevel-point needles.

Objective: Needle insertion is a common component of most diagnostic and therapeutic interventions. Needles with asymmetrically sharpened points such as the bevel point are ubiquitous. Their insertion path is typically curved due to the rudder effect at the point. However, the common planned path is straight, leading to targeting errors. We present a simple technique that may substantially reduce these errors. The method was inspired by practical experience, conceived mathematically, and refined experimentally. Methods: Targeting errors are reduced by flipping the bevel on the opposite side (rotating the needle 180° about its axis), at a certain depth during insertion. The ratio of the flip depth to the full depth of insertion is defined as the flip depth ratio (FDR). Based on a model, FDR is constant 0.3. Results: Experimentally, the ratio depends on the needle diameter, 0.35 for 20Ga and 0.45 for 18Ga needles. Thinner needles should be flipped a little shallower, but never less than 0.3. Conclusion: Practically, a physician may expect to reduce ∼80% of needle deflection errors by simply flipping the needle. The technique may be used by hand or with guidance devices.

MR Safe Robot, FDA Clearance, Safety and Feasibility Prostate Biopsy Clinical Trial.

Compatibility of mechatronic devices with the MR environment has been a very challenging engineering task. After over a decade of developments, we report the successful translation to clinical trials of our MR Safe robot technology. MrBot is a 6-degree-of-freedom, pneumatically actuated robot for transperineal prostate percutaneous access, built exclusively of electrically nonconductive and nonmagnetic materials. Its extensive pre-clinical tests have been previously reported. Here, we present the latest technology developments, an overview of the regulatory protocols, and technically related results of the clinical trial. The FDA has approved the MrBot for the biopsy trial, which was successfully performed in 5 patients. With no trajectory corrections, and no unsuccessful attempts to target a site, the robot achieved an MRI based needle targeting accuracy of 2.55 mm. To the best of our knowledge, this is the first robot approved by the FDA for the MR environment. The results confirm that it is possible to perform safe and accurate robotic manipulation in the MRI scanner, and the development of MR Safe robots is no longer a daunting technical challenge.

Geometric systematic prostate biopsy.

OBJECTIVE: The common sextant prostate biopsy schema lacks a three-dimensional (3D) geometric definition. The study objective was to determine the influence of the geometric distribution of the cores on the detection probability of prostate cancer (PCa). METHODS: The detection probability of significant (>0.5 cm3) and insignificant (<0.2 cm3) tumors was quantified based on a novel 3D capsule model of the biopsy sample. The geometric distribution of the cores was optimized to maximize the probability of detecting significant cancer for various prostate sizes (20-100cm3), number of biopsy cores (6-40 cores) and biopsy core lengths (14-40 mm) for transrectal and transperineal biopsies. RESULTS: The detection of significant cancer can be improved by geometric optimization. With the current sextant biopsy, up to 20% of tumors may be missed at biopsy in a 20 cm3 prostate due to the schema. Higher number and longer biopsy cores are required to sample with an equal detection probability in larger prostates. Higher number of cores increases both significant and insignificant tumor detection probability, but predominantly increases the detection of insignificant tumors. CONCLUSION: The study demonstrates mathematically that the geometric biopsy schema plays an important clinical role, and that increasing the number of biopsy cores is not necessarily helpful.

MRI-safe robot for targeted transrectal prostate biopsy: animal experiments.

OBJECTIVES: To study the feasibility and safety of using a magnetic resonance imaging (MRI)-safe robot for assisting MRI-guided transrectal needle placement and biopsy in the prostate, using a canine model. To determine the accuracy and precision afforded by the use of the robot while targeting a desired location in the organ. MATERIALS AND METHODS: In a study approved by the Institutional Animal Care and Use Committee, six healthy adult male beagles with prostates of at least 15 × 15 mm in size at the largest transverse section were chosen for the procedure. The probe portion of the robot was placed into the rectum of the dog, images were acquired and image-to-robot registration was performed. Images acquired after placement of the robot were reviewed and a radiologist selected targets for needle placement in the gland. Depending on the size of the prostate, up to a maximum of six needle placements were performed on each dog. After needle placement, robot-assisted core biopsies were performed on four dogs that had larger prostate volumes and extracted cores were analysed for potential diagnostic value. RESULTS: Robot-assisted MRI-guided needle placements were performed to target a total of 30 locations in six dogs, achieving a targeting accuracy of 2.58 mm (mean) and precision of 1.31 mm (SD). All needle placements were successfully completed on the first attempt. The mean time required to select a desired target location in the prostate, align the needle guide to that point, insert the needle and perform the biopsy was ∼ 3 min. For this targeting accuracy study, the inserted needle was also imaged after its placement in the prostate, which took an additional 6-8 min. Signal-to-noise ratio analysis indicated that the presence of the robot within the scanner bore had minimal impact on the quality of the images acquired. Analysis of intact biopsy core samples indicated that the samples contained prostatic tissues, appropriate for making a potential diagnosis. Dogs used in the study did not experience device- or procedure-related complications. CONCLUSIONS: Results from this preclinical pilot animal study suggest that MRI-targeted transrectal biopsies are feasible to perform and this procedure may be safely assisted by an MRI-safe robotic device.

Endocavity Ultrasound Probe Manipulators.

We developed two similar structure manipulators for medical endocavity ultrasound probes with 3 and 4 degrees of freedom (DoF). These robots allow scanning with ultrasound for 3-D imaging and enable robot-assisted image-guided procedures. Both robots use remote center of motion kinematics, characteristic of medical robots. The 4-DoF robot provides unrestricted manipulation of the endocavity probe. With the 3-DoF robot the insertion motion of the probe must be adjusted manually, but the device is simpler and may also be used to manipulate external-body probes. The robots enabled a novel surgical approach of using intraoperative image-based navigation during robot-assisted laparoscopic prostatectomy (RALP), performed with concurrent use of two robotic systems (Tandem, T-RALP). Thus far, a clinical trial for evaluation of safety and feasibility has been performed successfully on 46 patients. This paper describes the architecture and design of the robots, the two prototypes, control features related to safety, preclinical experiments, and the T-RALP procedure.

MRI-Safe Robot for Endorectal Prostate Biopsy.

This paper reports the development of an MRI-Safe robot for direct (interventional) MRI-guided endorectal prostate biopsy. The robot is constructed of nonmagnetic and electrically nonconductive materials, and is electricity free, using pneumatic actuation and optical sensors. Targeting biopsy lesions of MRI abnormality presents substantial clinical potential for the management of prostate cancer. The paper describes MRI-Safe requirements, presents the kinematic architecture, design and construction of the robot, and a comprehensive set of preclinical tests for MRI compatibility and needle targeting accuracy. The robot has a compact and simple 3 degree-of-freedom (DoF) structure, two for orienting a needle-guide and one to preset the depth of needle insertion. The actual insertion is performed manually through the guide and up to the preset depth. To reduce the complexity and size of the robot next to the patient, the depth setting DoF is remote. Experimental results show that the robot is safe to use in any MRI environment (MRI-Safe). Comprehensive MRI tests show that the presence and motion of the robot in the MRI scanner cause virtually no image deterioration or signal to noise ratio (SNR) change. Robot's accuracy in bench test, CT-guided in-vitro, MRI-guided in-vitro and animal tests are 0.37mm, 1.10mm, 2.09mm, and 2.58mm respectively. These values are acceptable for clinical use.

Geometric evaluation of systematic transrectal ultrasound guided prostate biopsy.

PURPOSE: Transrectal ultrasound guided prostate biopsy results rely on physician ability to target the gland according to the biopsy schema. However, to our knowledge it is unknown how accurately the freehand, transrectal ultrasound guided biopsy cores are placed in the prostate and how the geometric distribution of biopsy cores may affect the prostate cancer detection rate. MATERIALS AND METHODS: To determine the geometric distribution of cores, we developed a biopsy simulation system with pelvic mock-ups and an optical tracking system. Mock-ups were biopsied in a freehand manner by 5 urologists and by our transrectal ultrasound robot, which can support and move the transrectal ultrasound probe. We compared 1) targeting errors, 2) the accuracy and precision of repeat biopsies, and 3) the estimated significant prostate cancer (0.5 cm(3) or greater) detection rate using a probability based model. RESULTS: Urologists biopsied cores in clustered patterns and under sampled a significant portion of the prostate. The robot closely followed the predefined biopsy schema. The mean targeting error of the urologists and the robot was 9.0 and 1.0 mm, respectively. Robotic assistance significantly decreased repeat biopsy errors with improved accuracy and precision. The mean significant prostate cancer detection rate of the urologists and the robot was 36% and 43%, respectively (p <0.0001). CONCLUSIONS: Systematic biopsy with freehand transrectal ultrasound guidance does not closely follow the sextant schema and may result in suboptimal sampling and cancer detection. Repeat freehand biopsy of the same target is challenging. Robotic assistance with optimized biopsy schemas can potentially improve targeting, precision and accuracy. A clinical trial is needed to confirm the additional benefits of robotic assistance.

Personalized Renal Collecting System Mockup for Procedural Training Under Ultrasound Guidance.

Objective: In recent years, there has been increasing interest in the use of ultrasound guidance for endoscopic and percutaneous procedures. Kidney mockups could be used for training, however, available mockups are normally incompatible with ultrasound imaging. We developed a reproducible method to manufacture an ultrasound-compatible collecting system mockup that can be made at urology laboratories. Methods: Positive and negative molding methods were used. A three-dimensional (3D) digital model of a urinary collecting system and the overlying skin surface were segmented from computed tomography. A containment mold (negative) was made following the shape of the skin surface using 3D printing. A collecting system mold (positive) was also 3D printed, but made of a dissolvable material. The containment mold was filled with a gelatin formula with the collecting system mold submersed in situ within. After the gelatin solidified, a solution was used to dissolve the collecting system mold, but not the gelatin, leaving a cavity with the shape of the collecting system. The gelatin was extracted from the container mockup and the collecting system cavity was filled with water. The mockup was imaged with ultrasound to assess echogenicity and suitability for simulating ultrasound-guided procedures. Results: A clear shape corresponding to the collecting system was observed inside the gel structure. Structural integrity was maintained with no observable manufacturing marks or separation seams. Ultrasound images of the mockup demonstrated clear differentiation at the gelatin/water interface. A mock stone was placed in the collecting system and needle targeted to simulate percutaneous needle access. Conclusion: We developed a simple method to manufacture a personalized mockup of the renal collecting system of a patient that can be used for ultrasound-guided percutaneous needle access. Generic collecting system mockups can be used for training, and patient-specific models can be used to simulate and decide the best access path before a clinical case.

Integrated Real-Time Digital Measurement During Ureteroscopic Procedures for Nephrolithiasis: A Workflow Feasibility Study.

Introduction: Accurate estimation of stone fragment size during ureteroscopic lithotripsy procedures facilitates operative efficiency and predicts the safety of fragment extraction or spontaneous passage. Using a novel stone measurement software application, this study assesses the feasibility of performing integrated real-time digital stone measurement during ureteroscopy. Methods: This workflow feasibility study was conducted in two phases. First, in the ex vivo simulation, mock stone fragments were placed in a renal collecting system training model. A basket extraction task was performed using a digital ureteroscope, with and without digital stone measurement. The time required to perform the tasks was recorded and compared. Second, in the in vivo workflow trial, adult patients undergoing ureteroscopic stone procedures were prospectively enrolled. Intraoperative measurements of stone fragments were performed to determine the time required to complete the measurements. Technical failures and perioperative complications were recorded. Results: In the ex vivo simulation, 20 mock stones mimicking varied fragmentation conditions were tested in the training model. The mean completion time of the basketing task without vs with digital stone measurement was 16.5 seconds (range 10.2-33.7) vs 38.9 seconds (range 27.2-60.0). Mean additional time required to measure stones was 22.3 seconds (range 8.4-42.7). In the in vivo workflow trial, nine patients undergoing ureteroscopy were enrolled. A median of five fragments (range 3-10) were measured in each patient. Mean completion time for each measurement was 10.1 seconds (range 8.2-12.8). Mean total time required to perform digital measurement per procedure was 50.8 seconds (range 25.9-99.0). No technical failures or clinical complications were observed. Conclusions: Integrating real-time digital stone measurement during ureteroscopy is safe and feasible. The findings support clinical trials of digital stone measurement to enhance intraoperative decision-making during ureteroscopy.

Robotically assisted long bone biopsy under MRI: cadaver study results.

RATIONALE AND OBJECTIVES: We have designed and constructed an MR-safe robot made entirely of nonmetallic components with pneumatic actuators and optical encoders. The robot was developed to enable bone biopsies to be performed under magnetic resonance imaging (MRI) guidance in pediatric patients. The purpose of this study was to show the feasibility of using the robot for biopsy of the femur and tibia in a cadaver leg. Our long-term goal is to eliminate radiation exposure during bone biopsy procedures and provide more timely and accurate diagnosis for children with bone cancers and bone infections. METHODS: The MR-safe robot was mounted on the MRI table. A cadaver leg was procured from an anatomy supply house and placed on the MRI table. All required hospital precautions for infection control were taken. A total of 10 biopsy targets were sampled using MRI guidance: five from the femur and five from the tibia. A handheld, commercially available battery-powered bone drill was used to facilitate drilling through the cortex. After the study, the leg was scanned with CT to better visualize and document the bone biopsy sites. Both the MRI and CT images were used to analyze the results. RESULTS: All of the targets were successfully reached with an average targeting accuracy of 1.43 mm. A workflow analysis showed the average time for the first biopsy was 41 min including robot setup time and 22 min for each additional biopsy including the time for the repeat MRI scan used to confirm accurate targeting. The robot was shown to be MRI transparent, as no image quality degradation due to the use of the robot was detected. CONCLUSION: The results showed the feasibility of using an MR-safe robotic system to assist the interventional radiologist in performing precision bone biopsy under MRI guidance. Future work will include developing an MR-safe drill, improving the mounting of the robot and fixation of the leg, and moving toward first in child clinical trials.

Robotic Transrectal Ultrasound Guided Prostate Biopsy.

We present a robot-assisted approach for transrectal ultrasound (TRUS) guided prostate biopsy. The robot is a hands-free probe manipulator that moves the probe with the same 4 DoF that are used manually. Software was developed for three-dimensional (3-D) imaging, biopsy planning, robot control, and navigation. Methods to minimize the deformation of the prostate caused by the probe at 3-D imaging and needle targeting were developed to reduce biopsy targeting errors. We also present a prostate coordinate system (PCS). The PCS helps defining a systematic biopsy plan without the need for prostate segmentation. Comprehensive tests were performed, including two bench tests, one imaging test, two in vitro targeting tests, and an IRB-approved clinical trial on five patients. Preclinical tests showed that image-based needle targeting can be accomplished with accuracy on the order of 1 mm. Prostate biopsy can be accomplished with minimal TRUS pressure on the gland and submillimetric prostate deformations. All five clinical cases were successful with an average procedure time of 13 min and millimeter targeting accuracy. Hands-free TRUS operation, transrectal TRUS guided prostate biopsy with minimal prostate deformations, and the PCS-based biopsy plan are novel methods. Robot-assisted prostate biopsy is safe and feasible. Accurate needle targeting has the potential to increase the detection of clinically significant prostate cancer.

Transperineal prostate intervention: robot for fully automated MR imaging--system description and proof of principle in a canine model.

The study was approved by the animal care and use committee. The purpose of the study was to prospectively establish proof of principle in vivo in canines for a magnetic resonance (MR) imaging-compatible robotic system designed for image-guided prostatic needle intervention. The entire robot is built with nonmagnetic and dielectric materials and in its current configuration is designed to perform fully automated brachytherapy seed placement within a closed MR imager. With a 3.0-T imager, in four dogs the median error for MR imaging-guided needle positioning and seed positioning was 2.02 mm (range, 0.86-3.18 mm) and 2.50 mm (range, 1.45-10.54 mm), respectively. The robotic system is capable of accurate MR imaging-guided prostatic needle intervention within a standard MR imager in vivo in a canine model.

Multi-Imager Compatible, MR Safe, Remote Center of Motion Needle-Guide Robot.

We report the development of a new robotic system for direct image-guided interventions (DIGI; images acquired at the time of the intervention). The manipulator uses our previously reported pneumatic step motors and is entirely made of electrically nonconductive, nonmetallic, and nonmagnetic materials. It orients a needle-guide with two degrees of freedom (DoF) about a fulcrum point located below the guide using an innovative remote center of motion parallelogram type mechanism. The depth of manual needle insertion is preset with a third DoF, located remotely of the manipulator. Special consideration was given to the kinematic accuracy and the structural stiffness. The manipulator includes registration markers for image-to-robot registration. Based on the images, it may guide needles, drills, or other slender instruments to a target (OD < 10 mm). Comprehensive preclinical tests were performed. The manipulator is MR safe (ASTM F2503-13). Electromagnetic compatibility (EMC) testing (IEC 60601-1-2) of the system shows that it does not conduct or radiate EM emissions. The change in the signal to noise ratio of the MRI due to the presence and motion of the robot in the scanner is below 1%. The structural stiffness at the needle-guide is 33 N/mm. The angular accuracy and precision of the manipulator itself are 0.177° and 0.077°. MRI-guided targeting accuracy and precision in vitro were 1.71 mm and 0.51 mm, at an average target depth of ∼38 mm, with no adjustments. The system may be suitable for DIGI where [mm] accuracy lateral to the needle (2D) or [mm] in 3D is acceptable. The system is also multi-imager compatible and could be used with other imaging modalities.

Robotically Assisted Long Bone Biopsy Under MRI Imaging: Workflow and Preclinical Study.

RATIONALE AND OBJECTIVES: Our research team has developed a magnetic resonance imaging (MRI)-compatible robot for long bone biopsy. The robot is intended to enable a new workflow for bone biopsy in pediatrics under MRI imaging. Our long-term objectives are to minimize trauma and eliminate radiation exposure when diagnosing children with bone cancers and bone infections. This article presents our robotic systems, phantom accuracy studies, and workflow analysis. MATERIALS AND METHODS: This section describes several aspects of our work including the envisioned clinical workflow, the MRI-compatible robot, and the experimental setup. The workflow consists of five steps and is intended to enable the entire procedure to be completed in the MRI suite. The MRI-compatible robot is MR Safe, has 3 degrees of freedom, and a remote center of motion mechanism for orienting a needle guide. The accuracy study was done in a Siemens Aera 1.5T scanner with a long bone phantom. Four targeting holes were drilled in the phantom. RESULTS: Each target was approached twice at slightly oblique angles using the robot needle guide for a total of eight attempts. A workflow analysis showed the average time for each targeting attempt was 32 minutes, including robot setup time. The average 3D targeting error was 1.39 mm with a standard deviation of 0.40 mm. All of the targets were successfully reached. CONCLUSION: The results showed the ability of the robotic system in assisting the radiologist to precisely target a bone phantom in the MRI environment. The robot system has several potential advantages for clinical application, including the ability to work at the MRI isocenter and serve as a steady and precise guide.

Automatic brachytherapy seed placement under MRI guidance.

The paper presents a robotic method of performing low dose rate prostate brachytherapy under magnetic resonance imaging (MRI) guidance. The design and operation of a fully automated MR compatible seed injector is presented. This is used with the MrBot robot for transperineal percutaneous prostate access. A new image-registration marker and algorithms are also presented. The system is integrated and tested with a 3T MRI scanner. Tests compare three different registration methods, assess the precision of performing automated seed deployment, and use the seeds to assess the accuracy of needle targeting under image guidance. Under the ideal conditions of the in vitro experiments, results show outstanding image-guided needle and seed placement accuracy.

An evaluation method for the mechanical performance of guide-wires and catheters in accessing the upper urinary tract.

The placement of guide-wires and catheters to gain access to the upper urinary tract can induce undesirable stresses on tissues. Previous studies have characterized the performance of wires and catheters by evaluating their physical properties such as stiffness and friction coefficient. However, the results of these studies do not directly quantify the wire's effects on tissues. Furthermore, the individual physical properties of wires and catheters investigated in previous studies cannot be simply summed up to characterize the behavior of an entire wire/catheter ensemble. This paper presents an objective method for testing guide-wires and catheters that estimates the forces applied by these instruments to anatomical structures during urological procedures. Our model utilizes a computer-controlled test stand that simulates a urological environment by including a tortuous path and a stone obstruction. Experimental results using this model show significant promise in reflecting the performance of guide-wires and catheters measuring the stress exerted upon relevant anatomical structures. Furthermore, due to the modularity of the approach, the model can be easily reconfigured to simulate environments relevant to other medical fields.

A New Type of Motor: Pneumatic Step Motor.

This paper presents a new type of pneumatic motor, a pneumatic step motor (PneuStep). Directional rotary motion of discrete displacement is achieved by sequentially pressurizing the three ports of the motor. Pulsed pressure waves are generated by a remote pneumatic distributor. The motor assembly includes a motor, gearhead, and incremental position encoder in a compact, central bore construction. A special electronic driver is used to control the new motor with electric stepper indexers and standard motion control cards. The motor accepts open-loop step operation as well as closed-loop control with position feedback from the enclosed sensor. A special control feature is implemented to adapt classic control algorithms to the new motor, and is experimentally validated. The speed performance of the motor degrades with the length of the pneumatic hoses between the distributor and motor. Experimental results are presented to reveal this behavior and set the expectation level. Nevertheless, the stepper achieves easily controllable precise motion unlike other pneumatic motors. The motor was designed to be compatible with magnetic resonance medical imaging equipment, for actuating an image-guided intervention robot, for medical applications. For this reason, the motors were entirely made of nonmagnetic and dielectric materials such as plastics, ceramics, and rubbers. Encoding was performed with fiber optics, so that the motors are electricity free, exclusively using pressure and light. PneuStep is readily applicable to other pneumatic or hydraulic precision-motion applications.

Safety and Feasibility of Direct Magnetic Resonance Imaging-guided Transperineal Prostate Biopsy Using a Novel Magnetic Resonance Imaging-safe Robotic Device.

OBJECTIVE: To evaluate safety and feasibility in a first-in-human trial of a direct magnetic resonance imaging (MRI)-guided prostate biopsy using a novel robotic device. METHODS: MrBot is an MRI-safe robotic device constructed entirely with nonconductive, nonmetallic, and nonmagnetic materials and developed by our group. A safety and feasibility clinical trial was designed to assess the safety and feasibility of a direct MRI-guided biopsy with MrBot and to determine its targeting accuracy. Men with elevated prostate-specific antigen levels, prior negative prostate biopsies, and cancer-suspicious regions (CSRs) on MRI were enrolled in the study. Biopsies targeting CSRs, in addition to sextant locations, were performed. RESULTS: Five men underwent biopsy with MrBot. Two men required Foley catheter insertion after the procedure, with no other complications or adverse events. Even though this was not a study designed to detect prostate cancer, biopsies confirmed the presence of a clinically significant cancer in 2 patients. On a total of 30 biopsy sites, the robot achieved an MRI-based targeting accuracy of 2.55 mm and a precision of 1.59 mm normal to the needle, with no trajectory corrections and no unsuccessful attempts to target a site. CONCLUSION: Robot-assisted MRI-guided prostate biopsy appears safe and feasible. This study confirms that a clinically significant prostate cancer (≥5-mm radius, 0.5 cm3) depicted in MRI may be accurately targeted. Direct confirmation of needle placement in the CSR may present an advantage over fusion-based technology and gives more confidence in a negative biopsy result. Additional study is warranted to evaluate the efficacy of this approach.

A surface tension magnetophoretic device for rare cell isolation and characterization.

The cancer community continues to search for an efficient and cost-effective technique to isolate and characterize circulating cells (CTCs) as a 'real-time liquid biopsy'. Existing methods to isolate and analyze CTCs require various transfer, wash, and staining steps that can be time consuming, expensive, and led to the loss of rare cells. To overcome the limitations of existing CTC isolation strategies, we have developed an inexpensive 'lab on a chip' device for the enrichment, staining, and analysis of rare cell populations. This device utilizes immunomagnetic positive selection of antibody-bound cells, isolation of cells through an immiscible interface, and filtration. The isolated cells can then be stained utilizing immunofluorescence or used for other downstream detection methods. We describe the construction and initial preclinical testing of the device. Initial tests suggest that the device may be well suited for the isolation of CTCs and could allow the monitoring of cancer progression and the response to therapy over time.

Robotic prostate surgery.

The increasing popularity of robot-assisted radical prostatectomy has put the field of robotics in the spotlight. However, the relationship between medical robotics and the field of urology is older than most urologists know and it will most likely have a bright future beyond any contemporary application. The objective of this review is to provide an insight into the fundamentals of medical robotics and to highlight the history, the present and the future of urological robotic systems with an emphasis on robotic prostate interventions.